Trials / Completed
CompletedNCT01396356
Atrial Fibrillation Ablation on Gastric Motility "The AF Gut Study"
Impact of Atrial Fibrillation Ablation on Gastric Motility "The AF Gut Study"
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (estimated)
- Sponsor
- Dhanunjaya Lakkireddy, MD, FACC · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
You are being scheduled to undergo an ablation procedure to treat your atrial fibrillation. Complications of ablation procedures include damage to structures near the heart from the heat energy used during the ablation procedure. These complications include damage to the esophagus (the tube through which food passes when you swallow) and stomach. A rare but often fatal complication resulting from severe heat damage is called an atrio-esophageal fistula (an abnormal connection between the heart and esophagus). However, the frequency of minimal damage to the esophagus or nerves of the gut that may go unnoticed are not known. This study is designed to determine how often atrial fibrillation ablation causes problems with the stomach and esophagus.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | GI procedures | If you agree to participate in the study, you will undergo a series of tests about a week before the expected ablation procedure. The same tests will be repeated 24-48 hours after the ablation. These tests include esophageal manometry, gastric emptying scan, sham feeding test and completing a symptoms questionnaire. |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2011-07-18
- Last updated
- 2013-01-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01396356. Inclusion in this directory is not an endorsement.